德国拜耳拜瑞妥说明书

German Bayer instructions:

[Indications/Function and Indications] 1. For adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE). 2. Used to treat venous thrombosis (DVT) in adults and reduce the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT. 3. For use in adult patients with nonvalvular atrial fibrillation who have one or more risk factors (e.g., congestive heart failure, hypertension, age ≥75 years, diabetes, history of stroke or transient ischemic attack) to reduce the risk of stroke and systemic embolism.

[Usage and Dosage] Xarelto is an oral medicine. 10 mg can be taken with food or alone. Xarelto 15 mg or 20 mg tablets should be taken with food.

【Adverse reaction】>10%: bleeding. 1%-10%: dizziness (2%), insomnia (2%), anxiety (1%), depression (1%), fatigue (1%), syncope (1%), wound discharge (3%), itching (2%), skin blisters (1%), Abdominal pain (3%), major bleeding (≤4%), elevated serum aminotransferases (>3xULN (upper limit of reference value): 2%), back pain (3%), limb pain (2%), muscle spasm (1%), bronchiectasis, and pulmonary hemorrhage.

[Precautions] Renal impairment: In patients with severe renal impairment (creatinine clearance <30 mL/min), the plasma concentration of rivaroxaban may be significantly increased, leading to an increased risk of bleeding. Xarelto is not recommended for patients with creatinine clearance <15 mL/min. Xarelto should be used with caution in patients with a creatinine clearance of 15-29 mL/min. Rivaroxaban should be used with caution in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) when used concomitantly with other drugs that may increase rivaroxaban plasma concentrations.

Hepatic Impairment: In cirrhotic patients with moderate hepatic impairment (Child Pugh category B), plasma concentrations may be significantly elevated, resulting in an increased risk of bleeding. Rivaroxaban is contraindicated in patients with liver disease associated with coagulation abnormalities and clinically relevant risk of bleeding. Xarelto can be used with caution in patients with cirrhosis who have moderate hepatic impairment (Child Pugh category B) and who do not have coagulation abnormalities.

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